warnings and cautions
WARNINGS AND PRECAUTIONS GENERAL Sulfur, by itself, is not toxic to our bodies. However, some people are allergic to relatives of sulfur such as sulfites and sulfa drugs. Certain sulfites can trigger asthma and other allergic reactions in people who are sensitive. Sulfa drugs can cause hypoglycemia (low blood sugar), skin rashes, high fever, headache, fatigue, and gastric problems for people with alpha drug allergies. Tell your health care provider if you think you may be allergic to sulfur-containing substances. Folic acid, when administered in daily doses above 0.1mg, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). 5-methyltetrahydrofolate may be less likely than folic acid to mask vitamin B12 deficiency. 9-10 Folate therapy alone is inadequate for the treatment of a B12 deficiency. Interaction with Drugs: Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. No decrease in effectiveness of drugs has been reported with the use of XIZFLUS. Hydrogen sulfide may induce cytochrome P450 2B6 7 and 2E1 8 , therefore it may decrease the half-life of medications metabolized by these enzymes. Careful monitoring of concomitant medications metabolized by these enzymes is recommended. ADVERSE REACTIONS Mild gastrointestinal (GI) issues such as flatulence and nausea were observed in sodium polysulthionate patients. 1 All GI incidences were categorized as “mild” and no patients discontinued due to adverse events1. Allergic reactions have not been reported following the use of oral sodium polysulthionate. USE IN SPECIFIC POPULATIONS Pregnancy: XIZFLUS has not been studied in pregnant women. The choice to administer XIZFLUS during pregnancy is at the clinical discretion of the prescribing physician. Labor and Delivery/NursingMothers: XIZFLUS has not been studied in labor and delivery. The choice to administer XIZFLUS during labor and delivery is at the clinical discretion of the prescribing physician. Pediatric Use: XIZFLUS has not been studied in a pediatric population. The choice to administer XIZFLUS in pediatric populations is at the clinical discretion of the prescribing physician. Geriatric Use: Clinical studies with XIZFLUS have not included sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger subjects. OVERDOSAGE: No specific information is available on the treatment of overdosage with XIZFLUS. XIZFLUS has been self-affirmed as Generally Recognized as Safe (GRAS). The highest level of sodium polysulthionate consumption has been 1,600MG per day in clinical studies although anecdotal reports of 3,000mg per day have used without adverse events..